UNICORNS: Uveitis in Childhood Prospective National Cohort Study
UNICORNS
Uveitis in Childhood Prospective National Cohort Study
1 other identifier
observational
250
1 country
31
Brief Summary
Childhood uveitis (inflammation inside the eye) is an uncommon disorder that carries the risk of blindness. Inadequate treatment of active inflammation has been shown to be related to a poor outcome. There has been no population-based, prospective longitudinal study of all-cause childhood uveitis, with resultant limitations in the evidence base used to counsel affected families, balance treatment decisions, or plan further research. The aim of the study is to describe the characteristics of childhood-onset uveitis and describe outcomes. The investigators shall also aim to identify the socio-demographic, clinical, biological and treatment-related determinants of outcome. Early (1-2 years following diagnosis) outcomes will be described in the first instance: However, through the creation of a national inception cohort, the investigators shall enable longer-term studies of outcome for affected children and families. There will be no change to routine clinical care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2020
CompletedStudy Start
First participant enrolled
October 22, 2020
CompletedFirst Posted
Study publicly available on registry
May 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedOctober 4, 2024
September 1, 2024
5.1 years
October 16, 2020
October 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of ocular complications
New incident of sight threatening ocular complications, including glaucoma, cataract and macular oedema
Up to 3 years
Pediatric Quality of Life Inventory Score
Quality of life (patient reported outcomes) using Pediatric Quality of Life Inventory (PedsQL) in which items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life)
Up to 3 years
Secondary Outcomes (4)
Corticosteroid exposure
Up to 3 years
Attainment of disease control
Up to 3 years
Health Utility
Up to 3 years
Change in Pediatric Quality of Life Inventory Score
Over one year from baseline to year one
Study Arms (1)
Childhood Uveitis
Children \<18 years old newly diagnosed with non-infectious uveitis
Eligibility Criteria
Children those aged under 18 years old (at diagnosis) who are newly diagnosed with uveitis newly diagnosed with uveitis (within previous 6 months)
You may qualify if:
- Children newly diagnosed with uveitis (within previous 6 months)
- Age \< 18years
You may not qualify if:
- Uveitis due to malignancy
- Uveitis due to ocular trauma (including iatrogenic, ie intraocular surgery)
- Uveitis due to confirmed ocular infection
- Children with developmental disorders or impairments which prevent their self-report of their function level or quality of life
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Belfast Royal Victoria Hospital NHS Foundation Trust
Belfast, BT9 7AB, United Kingdom
Birmingham Women's and Children's Hospital NHS Foundation Trust
Birmingham, B4 6NH, United Kingdom
Royal Bournemouth Christchurch Hospitals NHS Foundation Trust
Bournemouth, BH7 7DW, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD9 6RJ, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, BS1 3NU, United Kingdom
Cambridge University Hospital NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Cardiff and Vale University Health Board Hospitals
Cardiff, CF14 4XW, United Kingdom
Mid Essex Hospital Trust
Chelmsford, CM1 7ET, United Kingdom
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Princess Alexandra Eye Pavilion
Edinburgh, EH1 3EG, United Kingdom
Royal Children's Hospital
Glasgow, G51 4TF, United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, NR31 6LA, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, HU3 2JZ, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF, United Kingdom
Alder Hey Hospital NHS Foundation Trust
Liverpool, L12 2AP, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD, United Kingdom
Royal Free London NHS Foundation Trust
London, NW3 2QG, United Kingdom
St Thomas' Hospital
London, SE1 7EH, United Kingdom
Great Ormond Street Hospital NHS Foundation Trust
London, WC1N 3JH, United Kingdom
Maidstone and Tunbridge Wells NHS Trust
Maidstone, ME16 9QQ, United Kingdom
Manchester University NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, NE1 4LP, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, NR4 7UY, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU, United Kingdom
Sussex Eye Hospital and Royal Alexandra Children's Hospital
Redhill, RH1 5RH, United Kingdom
Sheffield Children's Hospitals NHS Foundation Trust
Sheffield, S10 2TH, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, SS0 0RY, United Kingdom
Royal London Hospital
Whitechapel, E1 1FR, United Kingdom
York Teaching Hospital NHS Foundation Trust
York, YO31 8HE, United Kingdom
Related Publications (1)
Kellett S, Rahi JS, Dick AD, Knowles R, Tadic V, Solebo AL. UNICORNS: Uveitis in childhood prospective national cohort study protocol. F1000Res. 2023 Aug 30;9:1196. doi: 10.12688/f1000research.26689.2. eCollection 2020.
PMID: 38435080BACKGROUND
Related Links
Biospecimen
Saliva, Stool, Tears and Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ameenat L Solebo
University College London (UCL) Great Ormond Street Institute of Child Health
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2020
First Posted
May 23, 2022
Study Start
October 22, 2020
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
October 4, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share
Authorised collaborators will be granted access to aggregated anonymised data, following review of their research protocol study PI and Co-Is. Data and material transfer agreements will be required to be completed, in order to ensure regulatory compliance and that the interests of the participants are upheld and respected throughout.